Sandra Sather
FDA Issues Warning Letter Regarding Patient ...

10/22/2024

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On August 20th, 2024 the US Food and Drug Administration (FDA) issued a warning letter as a result of an FDA Bioresearch Monitoring (BIMO) Program inspection. The inspection observation was that improper dosing instructions were given to a pediatric patient. Per 21 CFR 312.60, the investigator is responsible for ensuring the study is conducted according to the protocol.

FDA Issues Warning Letter Regarding Patient Overdose
Guest User
FDA Updates Guidance to Address the Spread of ...

10/10/2024

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The internet is the leading source of health information for most consumers, patients, and healthcare providers, which has led to growing concerns that the spread of misinformation on the internet will put the public at risk of using unsafe or ineffective treatments or therapies. To address the issue the US Food and Drug Administration (FDA) has updated the draft guidance “Addressing Misinformation About Medical Devices and Prescription Drugs Questions and Answers - Guidance for Industry” to inform firms about how to voluntarily address misinformation about their medical products.

FDA Updates Guidance to Address the Spread of Misinformation
Sandra Sather
Real-World Data and Evidence Generation with ...

10/01/2024

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“Q&A with FDA” is the US Food and Drug Administration’s (FDA) podcast that began in 2022 which answers frequently asked questions by interviewing FDA staff members. The most recent episode was released on August 16th, 2024 titled “Real-World Data and Evidence Generation with Dr. Hilary Marston” hosted by Dr. Sara Roach interviewing Dr. Marston, the FDA’s Chief Medical Officer.

Real-World Data and Evidence Generation with Dr. Hilary Marston
Sandra Sather
New Draft Guidance on Predetermined Change ...

09/18/2024

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A new draft guidance for industry was released on August 22, 2024 by the US Food and Drug Administration (FDA) on Predetermined Change Control Plans (PCCP) for Medical Devices. The draft guidance provides an in-depth history of the origins of PCCPs and how the concept of device changes not requiring new 510(k) submissions has already made in an appearance in other FDA guidances.

New Draft Guidance on Predetermined Change Control Plans for Medical Devices
Sandra Sather
FDA Announces Upcoming Webinar to Discuss the ...

09/10/2024

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In August 2024, the US Food and Drug Administration (FDA) released a final guidance for industry on drug-drug interactions (DDI) with The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) titled: M12 Drug Interaction Studies. The guidance is intended to set the global standard and framework for conducting and reporting DDI studies in order to improve the efficacy of drugs as well as the safety and predictability of potential interactions between different drugs.

FDA Announces Upcoming Webinar to Discuss the New Guidance for Industry: ICH M12 Drug-Drug Interaction Studies

Guidance on Adaptive Design for Clinical Trials Released for Comments!

12/04/2019

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The Food and Drug Administration (FDA) released a final guidance “Adaptive Designs for Clinical Trials of Drugs and Biologics” for comments. An adaptive designed clinical trial means that during the trial, the design can be changed based on an interim analysis of the data collected from subjects already enrolled. This means that the trial design could be altered during enrollment to increase the type of subjects that are more likely to benefit or reduce those who may be at greater risk for adverse effect. This could reduce the time needed to determine if the investigational product is safe and effective and reduce risks to subjects. The final guidance clarifies principles for the design, conduct, and reporting of adaptive clinical trials for evaluation of safety and effectiveness of drugs and biologics and is part of FDA’s modernization efforts.

Clinical Safety Data Management eLearning Course Now Available for Purchase!

11/21/2019

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What is ICH E2A? ICH E2A provides guidance on how to handle expedited safety reporting and includes important definitions and standards. Following harmonized standards and procedures for safety reporting on investigational products ensures Good Clinical Practice (GCP).

Critical Thinking and Artificial Intelligence

11/14/2019

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In the ever-evolving world of increasing automation, computers and artificial intelligence are taking over jobs that humans use to do. Self-driving cars and home assistant devices may be helpful, but humans are still necessary for their critical thinking skills that artificial intelligence cannot replace.

FDA Framework for Use of Real-World Evidence

11/05/2019

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The U.S. Food and Drug Administration (FDA) released a Framework in December 2018 for the use of real-world evidence, which is not routinely collected during the course of a clinical trial. Under the 21st Century Cures Act, the FDA was to establish a program to evaluate the use of real-world evidence to help support a new indication for an approved drug or to satisfy post approval requirements. RWE evidence has been used by the FDA for some time to monitor drug safety, but its use to determine effectiveness has been limited.